Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate

NCT ID: NCT06282848

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:

• the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates
• the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.

Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid.

Detailed Description

This proposed study is a 24-month longitudinal randomized trial that aims to investigate myopia development after either topical application of 0.05% atropine or prescription of DIMS lens in children with various predicted myopia progression rates by their initial retinal responses obtained by multifocal ERG. This will help elucidate the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates. The retinal electrophysiological investigation will help determine the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.

80 subjects in either gender aged 7 to 9 years will be recruited in this study. They should have spherical equivalent refractive error between -0.5D and -4D in both eyes with best-corrected visual acuity of logMAR 0.00 or better. All should have normal eye health and without systemic diseases or epilepsy. They have not received any myopia control previously. Eligible subjects will have a baseline eye examination and have the first 6-month period monitoring the refractive and ocular changes compared with the baseline control data. After these 6 months, subjects will be classified into either fast or slow myopia progression group in accordance with the results of electrophysiology results and then will further be randomly allocated either intervention group: pharmacological treatment group (daily topical 0.05% atropine) or control group: non-pharmacological treatment group (daily wear of Defocused Incorporated Multiple Segments - DIMS lenses), for 18 months study period with 6-month interval regular follow up.

The primary outcomes are the changes of refractive errors and axial length after different types of interventions and the secondary outcomes are the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Atropine 0.05%

Group receiving atropine treatment for 18 months after 6 months of monitoring without intervention

Group Type: ACTIVE_COMPARATOR

Atropine 0.05%

Intervention Type: DRUG

Topical application

DIMS lens

Group receiving DIMS lens treatment for 18 months after 6 months of monitoring without intervention

Group Type: EXPERIMENTAL

DIMS lens

Intervention Type: DEVICE

Spectacle wear

Interventions

Atropine 0.05%

Topical application

Intervention Type: DRUG

DIMS lens

Spectacle wear

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• be aged between 7 and 9 years
• have no reported eye disorder and no family history of eye disease
• be able to participate in this study for 24 months
• not have any current or history of epilepsy
• not have any current or history of asthma
• have refractive error between 0.50 D and 4.00 D and less than 1.50D of astigmatism with best corrected visual acuity of LogMAR 0.0 or better
• have no detected eye diseases or disorders after eye examination, except myopia

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Henry HL Chan, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry HL CHAN, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

School of Optometry, Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Henry HL CHAN, PhD

Role: CONTACT

henryhl.chan@polyu.edu.hk

85227667937

Kaiyip CHOI, PhD

Role: CONTACT

kaiyip.choi@polyu.edu.hk

85234002934

Facility Contacts

Henry HL Chan, PhD

Role: primary

henryhl.chan@polyu.edu.hk

85227667937

Kaiyip Choi, PhD

Role: backup

kaiyip.choi@polyu.edu.hk

85234002934

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HongKongPU_Optometry4

Identifier Type: -

Identifier Source: org_study_id